AD, Quality Systems

Technical Operations San Diego, CA


Description

About Pacira

Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.

Why work with us?

Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people.  At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.

This position oversees the development, implementation, and management of an effective Quality Management System (QMS), which supports the manufacture and testing of clinical and commercial aseptic drug products in compliance with applicable regulatory requirements for Pacira’s Science Center Campus and Headquarters. 

Responsibilities:

  • Provide exceptional customer service to Pacira’s internal and external customers in all assigned tasks and foster a GMP compliance culture.
  • Develop the Quality Systems strategy in alignment with Quality Assurance strategy to meet compliance goals.
  • Effectively organize, lead, manage and develop the Quality Systems team, to include the Document Control and GMP Training functions, through a period of rapid change.
  • Monitor performance of the QMS (audit data, metrics, and trends), analyze, and implement process improvements to the QMS to ensure effectiveness, efficiency and ongoing regulatory compliance.
  • Maintain controlled documents and records of compliance activities.
  • Develop, implement, manage, and renew at an appropriate frequency QMS metrics, project dashboards, and department plans.
  • Develop and administer the corrective and preventive action system, inspection management processes, and management review.
  • Liaise across the business to build relationships, remove silos, communicate, train, and support internal customers with QMS and GMP compliance, processes, policies and procedures.
  • Write, review and revise as necessary QMS policies and procedures.
  • Support regulatory inspections and partner audits.
  • Other duties as assigned.

Supervisory Responsibilities:

  • Supervise staff to support the Quality Systems function.

Qualifications:

  • Minimum of 10 years of relevant pharmaceutical industry, Quality Assurance, experience
  • Demonstrated managerial experience in Quality Assurance or related function
  • BS/BA degree in a scientific or business discipline or equivalent experience
  • Prior experience with ComplianceWire and/or MasterControl desirable
  • Must have a working knowledge of Quality Systems and GMP requirements (US and EMEA).
  • Ability to organize, analyze, plan, and develop the Quality Systems function.
  • Ability to delegate effectively, lead staff, and manage Quality Systems activities in a fast-paced environment.
  • Knowledge of and working experience with Document Systems, Change Management, Training, and Auditing.
  • Familiarity with GCP requirements.
  • Ability to manage multiple responsibilities with a high degree of self-motivation.
  • Ability to work proactively with all departments to make decisions and solve quality problems.
  • Strong communication, presentation, interpersonal, and organizational skills.
  • Proficiency in Microsoft Excel, PowerPoint, Word, and Adobe Acrobat applications.
  • Flexibility to work varying schedules to support occasional weekend, holiday and off shift work hours.

EEO Statement

Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.

At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.